🇧🇷 ANVISA (Brasil) denies registration

About a week ago, the national regulatory agency from Brazil (ANVISA) denied the registration of a new product, ‘Chlormethine Hydrochloride’, among the reasons … Improper investigation of Nitrosamines Risk!

  • According to the risk assessments regarding the presence of potential genotoxic impurities and nitrosamines, it was not informed whether the manufacturer’s starting material was evaluated
  • It should be noted that effective communication between drug and starting material manufacturers is relevant to ensure the exchange of critical information that may impact the quality of the drug.

Risk Assessment is an essential part of Nitrosamine Investigation and mitigation … we continue to see manufacturers that their first reaction is to send samples to be analyzed for 6 or 7 nitrosamine impurities! #PleaseNotMore #RiskAssessment